Device Classification Name |
bandage, liquid
|
510(k) Number |
K953131 |
Device Name |
EXUSORB STERILE ABSORBENT |
Applicant |
O.R. RESOURCES, INC. |
212 BRINY AVE., SUITE A-4 |
POMPANO BEACH,
FL
33062
|
|
Applicant Contact |
ALFRED J LINDSEY |
Correspondent |
O.R. RESOURCES, INC. |
212 BRINY AVE., SUITE A-4 |
POMPANO BEACH,
FL
33062
|
|
Correspondent Contact |
ALFRED J LINDSEY |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 07/06/1995 |
Decision Date | 09/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|